Informed Decision-Making with and for People with Dementia-Efficacy of the PRODECIDE Education Program for Legal Representatives: A Randomized Controlled Trial (PRODECIDE-RCT) and Process Evaluation.

Legal representatives take a major role in healthcare decisions with and for people with dementia, but only a minority has a qualification in this field. The aim was to evaluate the efficacy of the PRODECIDE education program for legal representatives. In a prospective randomized controlled trial, legal representatives (volunteers and professionals, representing at least one person with dementia) were allocated (1:1 computer-generated block randomization) to the intervention (PRODECIDE education program) and control (standard care) groups. The primary outcome measure was knowledge, operationalized as the understanding of decision-making processes and in setting realistic expectations. Only data entry and analyses were blinded. A process evaluation in a mixed methods design was performed. We enrolled 218 legal representatives, and 216 were included in the primary analysis (intervention = 109, control = 107). The percentage of correct answers in the knowledge test post intervention was 69.0% in the intervention and 43.4% in the control group (difference 25.6%; CI 95%, 21.3 to 29.8; < 0.001). In the comparison of professional and voluntary representatives, professionals had 13.6% (CI 95%, 8.0 to 19.2; < 0.001) more correct answers. The PRODECIDE education program can improve the knowledge of legal representatives, an important prerequisite for evidence-based, informed decision-making.